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Behavioral Intervention

Mobile App for Multiple Myeloma (THRIVE-M Trial)

N/A

Recruiting

Led By Areej El-Jawahri, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients (aged 18 years or older) with relapsed multiple myeloma receiving 2nd or 3rd line therapy

Adult patients (aged 18 years or older) with newly diagnosed multiple myeloma receiving first-line therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 weeks

Awards & highlights

THRIVE-M Trial Summary

This trial will study if a mobile app can help improve quality of life for people with multiple myeloma.

Who is the study for?

This trial is for adults 18+ with multiple myeloma, whether newly diagnosed on first-line therapy, on maintenance therapy, or receiving their 2nd or 3rd line of treatment. Participants must understand and respond to English. Those with acute psychiatric conditions or unstable cognitive issues that prevent informed consent are excluded.Check my eligibility

What is being tested?

The trial tests the THRIVE-M psychosocial mobile app's effectiveness in improving life quality, reducing psychological distress, and alleviating fatigue among multiple myeloma patients compared to those who receive usual care without the app.See study design

What are the potential side effects?

Since THRIVE-M is a psychosocial app designed to support mental health and well-being rather than a drug, it may not have typical medical side effects but could potentially cause emotional discomfort if sensitive topics are addressed.

THRIVE-M Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult with multiple myeloma undergoing my 2nd or 3rd treatment.

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I am an adult with newly diagnosed multiple myeloma starting my first treatment.

THRIVE-M Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quality of Life as measured by the Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) scale

Secondary outcome measures

Anxiety Symptoms based on the Hospital Anxiety and Depression Scale

Depression Symptoms based on the Hospital Anxiety and Depression Scale

Fatigue based on the FACT-Fatigue Scale

+2 more

Other outcome measures

Coping based on the Measure of Current Status Part A (MOCS-A) scale

Gratitude based on the Gratitude Questionniare-6

Life Satisfaction based on the Satisfaction with Life Scale (SWLS)

+6 more

THRIVE-M Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: THRIVE-MExperimental Treatment1 Intervention

Participants will be recruited from the Massachusetts General Hospital Cancer Center and randomized in a 1:1 fashion, stratified by diagnosis type (newly diagnosed versus maintenance versus relapsed), to THRIVE-M versus usual care. Participants will use THRIVE-M following a diagnosis of multiple myeloma to learn how to cope with physical symptoms, articulate their needs and navigate relationships, and focus on self-care while living with multiple myeloma using an iPad provided by the study team or the participant's own iPad. Questionnaires (in person, over the computer or telephone, or by mail) will be completed by participants at predetermined days per protocol days.

Group II: Usual CareActive Control1 Intervention

Participants will be recruited from the Massachusetts General Hospital Cancer Center and randomized in a 1:1 fashion, stratified by diagnosis type (newly diagnosed versus maintenance versus relapsed), to THRIVE-M versus usual care. Questionnaires (in person, over the computer or telephone, or by mail) will be completed by participants at predetermined days per protocol days. Participants in the usual care arm will receive their usual care with the multiple myeloma team, including all routine supportive care resources (e.g., support from social work, psychology, or psychiatry) offered by the multiple myeloma team to all patients diagnosed with multiple myeloma. Patients in both the usual care and THRIVE-M group are permitted to use all supportive care services per usual care. We will track referrals to supportive care services in both groups by reviewing the Electronic Health Record (EHR).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,936 Previous Clinical Trials

13,198,601 Total Patients Enrolled

35 Trials studying Multiple Myeloma

2,518 Patients Enrolled for Multiple Myeloma

Areej El-Jawahri, MDPrincipal InvestigatorMassachusetts General Hospital

18 Previous Clinical Trials

4,392 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities remaining for individuals to take part in this clinical trial?

"Sadly, the information hosted on clinicaltrials.gov alludes to this trial's recruitment efforts being paused for now. Initially posted in October 25th of 2023 and last updated on the 2nd of said month, there are presently 815 other trials actively searching for participants instead."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Psychosocial Mobile Application (THRIVE-M) for Patients With Multiple Myeloma

El-Jawahri, Areej,M.D. 2023. "Psychosocial Mobile Application (THRIVE-M) for Patients With Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06073353.